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510(k) K820639

OBTURATION SYSTEM KIT by U.S. Shizai Corp. — Product Code EKM

K820639 is an FDA 510(k) premarket notification submitted by U.S. Shizai Corp. for the device "OBTURATION SYSTEM KIT". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. U.S. Shizai Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
March 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gutta-Percha
Device Class
Class I
Regulation Number
872.3850
Review Panel
DE
Submission Type

Other clearances by U.S. Shizai Corp.

  • K853841 — HARMO SONIC (February 4, 1986)
  • K822464 — OBTURATION GUTTA (November 3, 1982)
  • K802189 — DENTLOID (September 26, 1980)
  • K800951 — CASTA-LLOY (May 8, 1980)

Other clearances for product code EKM

  • K073369 — EI DOWNPAK BARRIER SLEEVES (February 27, 2008)
  • K070246 — DOWN PAK (February 16, 2007)
  • K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (June 26, 2006)
  • K042870 — ENDO TWINN (January 11, 2005)
  • K023819 — FIBERFILL SGP (March 26, 2003)
  • K971641 — ANTIBACTERIAL GUTTA PERCHA (July 21, 1997)
  • K970134 — THERMAPREP PLUS OVEN (March 21, 1997)
  • K931742 — INJECT-R FILL (May 27, 1993)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K915243 — TOUCH 'N HEAT MODEL 5002, MODIFICATION (January 21, 1992)

FDA data resources